Home NDC 49358-571 Mineral Tinted SPF 30
Product NDC 49358-571
11-digit product format 493580571
Labeler code 49358
Product ID 49358-571_36d86ec1-c63c-d417-e063-6394a90a5f9f
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide and Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler MDSolarSciences
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-01
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 20; 170 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49358-571-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49358-571-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49358-571-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49358-571-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49358-571-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49358-571-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49358-571-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Mineral Tinted SPF 30
Brand name suffix Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 20 mg/mL ZINC OXIDE 170 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49358-571-01 Mineral Tinted SPF 30Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min) 1 in 1 CARTON CREAM 1 2 49358-571-01 Mineral Tinted SPF 30Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min) 50 mL in 1 TUBE CREAM 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49358-571 MINERAL TINTED SPF 30 MINERAL TINTED SPF 30 BROAD SPECTRUM SUNSCREEN WATER RESISTANT (80 MIN) (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MDSOLARSCIENCES] 1 Current NDC, 2 package rows 20230910_adcd6881-fa25-4312-95e5-5b47102aa6b9.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 112 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Mineral Sunscreen ZINC OXIDE Natur LLC 365f3c48-15a6-2d32-e063-6394a90aad78 2025-12-16 Exact identifier application number: M020 Non Tinted Mineral Sunscreen ZINC OXIDE Natur LLC 365fffa2-b846-7dd3-e063-6394a90a47cb 2025-12-16 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE Natur LLC 36603550-9c3d-5e33-e063-6394a90adfc9 2025-12-16 Exact identifier application number: M020 Shield And Protect Tinted ZINC OXIDE TRILOGY LABORATORIES, LLC 37f00e51-1123-c04c-e063-6294a90abed8 2025-12-16 Exact identifier application number: M020 Shield And Protect ZINC OXIDE TRILOGY LABORATORIES, LLC 37f09dd5-084f-3c80-e063-6394a90a7a53 2025-12-16 Exact identifier application number: M020 Non Tinted Facial Mineral Protectant TITANIUM DIOXIDE, ZINC OXIDE EUROPEAN SKIN AND MASSAGE STUDIO 3766496f-231c-f98c-e063-6294a90aae08 2025-12-16 Exact identifier application number: M020 Tinted Facial Mineral Protectant TITANIUM DIOXIDE, ZINC OXIDE EUROPEAN SKIN AND MASSAGE STUDIO 3766b0d8-20e6-a227-e063-6294a90af4da 2025-12-16 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen ZINC OXIDE WECARE FRISCO PLLC 37515807-e29a-3916-e063-6394a90a1ffd 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen Broad Spectrum SPF 40 TITANIUM DIOXIDE, ZINC OXIDE WECARE FRISCO PLLC 374f866d-eb52-61e3-e063-6394a90a77c7 2025-12-16 Exact identifier application number: M020 Tinted Lip Protection TITANIUM DIOXIDE, ZINC OXIDE WECARE FRISCO PLLC 3750c23d-c3f8-fac3-e063-6394a90a135e 2025-12-16 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen Broad Spectrum SPF 40 ZINC OXIDE WECARE FRISCO PLLC 374fe86e-cbe8-f911-e063-6294a90a9600 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE WECARE FRISCO PLLC 37507b14-fc01-5e27-e063-6294a90afd50 2025-12-16 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen ZINC OXIDE WECARE FRISCO PLLC 375203a6-2ab8-2a80-e063-6294a90ada72 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE WECARE FRISCO PLLC 3751caa3-867e-5901-e063-6294a90ab6bd 2025-12-16 Exact identifier application number: M020 Auset Tinted Replenishing Daily Protection ZINC OXIDE SHAYLA BOGER SKIN THERAPY LLC 37da48d6-8f12-ec97-e063-6294a90a699c 2025-12-16 Exact identifier application number: M020 Morning Replenish ZINC OXIDE KATHY JONES AESTHETHICS LLC 37da711e-840b-2f2a-e063-6294a90ab16c 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE KATHY JONES AESTHETHICS LLC 37dab729-5988-5eba-e063-6294a90ac6b7 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tory Sullivan, M.D., P.A. 36241e60-f02a-50a7-e063-6394a90a6390 2025-12-16 Exact identifier application number: M020 Ageless All Fitz ZINC OXIDE A.Wall Beauty LLC 37670cb1-ac75-5049-e063-6394a90a4d0a 2025-12-16 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE Tory Sullivan, M.D., P.A. 36244b27-20e5-f370-e063-6294a90a1f6c 2025-12-16 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 49358-571-01 49358057101 1 TUBE in 1 CARTON (49358-571-01) / 50 mL in 1 TUBE 1 tube 2023-07-01 No No Current